NCT00141843已完成3 期
A Randomized Two-Way Blinded Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII,Refacto AF) With a Full Length Recombinant Factor VIII Preparation (FLrFVIII,Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients With Hemophilia A.
Wyeth is now a wholly owned subsidiary of Pfizer41 个研究点 分布在 13 个国家目标入组 100 人开始时间: 2005年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 41
- 主要终点
- To determine the incidence rate of Factor VIII inhibitors in the study patient population.To establish bioequivalence of ReFacto AF as compared to Advate using the one stage Factor VIII activity assay.
研究概览
简要总结
The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects with severe or moderately severe hemophilia A
- •A negative past medical history of a Factor VIII inhibitor
- •Age greater than or equal to 12 years
排除标准
- •A history of Factor VIII inhibitors
- •Presence of a bleeding disorder in addition to hemophilia
- •Known hypersensitivity to hamster protein
结局指标
主要结局
To determine the incidence rate of Factor VIII inhibitors in the study patient population.To establish bioequivalence of ReFacto AF as compared to Advate using the one stage Factor VIII activity assay.
次要结局
- To characterize the efficacy of ReFActo AF in preventing and treating bleeding episodes during prophylaxis.To characterize PK of ReFacto AF as compared to Advate over time.
研究者
研究点 (41)
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